ARTICLE SUMMARY:
Singapore eyes AI device exemptions. Excerpted from Pathways’ Picks May 21: FDA Eyes User Fee Changes, EU Plans Orphan/Peds Panel, and More.
The Health Sciences Authority in Singapore is proposing to expand its regulatory exemptions for artificial intelligence software as a medical device (AI-SaMD) developed by healthcare institutions for their own patients. Established regulations already allow individual healthcare facilities to develop AI software for in-house use without needing to comply with manufacturer license and product registration requirements. Under a May 19 proposal, however, certain public health clusters will be able to develop AI tools that all institutions within the network could employ under a licensing exemption. “This is so that public healthcare as a whole can reap the benefits of these customized AI-SaMDs, and also avoid duplicative costs if each institution has to develop its own AI-SaMD to perform the same function,” HSA writes in its consultation (comments due June 19) on the proposal. The policy would be limited to the set of institutions associated with the Ministry of Health’s Office for Healthcare Transformation, Synapxe (the so-called HealthTech agency of Singapore), and other specific public healthcare clusters. Institutions would be required to notify HSA upon deployment and conduct postmarket controls.